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Recall Observatory FDA recall evidence

Drug product

Prolotherapy with Phenol (Dextrose 25%, Glycerin 10%, Lidocaine HCl 10%, Bupivacaine HCl 0.625%, Phenol 1%, QS SWI), 5 mL vial, Rx Only, Hartley Medical, (888) 671-2888

D-1829-2015

August 17, 2015

Class I

Product summary

Firm
Hartley Medical Center Pharmacy, Incorporated
Event
Event 71990
Status
Terminated
Classification
Class I
Quantity
14 vials
Official record key
drug-enforcement:D-1829-2015

Official wording

Reason: Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.

Code information: Lot: RX # 323132, Exp. 10/06/2015; RX # 328690, Exp. 12/1/2015

Distribution pattern: CA and NV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.